Ingenia Ambition S and Ingenia Ambition X
K-Number: K181479 · 2018-08-03
Decision Date2018-08-03
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Ingenia Ambition S and Ingenia Ambition X is a medical device manufactured by Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2018-08-03 under approval number K181479. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Ingenia Ambition S and Ingenia Ambition X?
Ingenia Ambition S and Ingenia Ambition X is a medical device that received FDA 510(k) clearance on 2018-08-03. It is manufactured by Philips Medical Systems Nederland B.V.. The 510(k) number is K181479.
When was Ingenia Ambition S and Ingenia Ambition X approved by the FDA?
Ingenia Ambition S and Ingenia Ambition X received FDA 510(k) clearance on 2018-08-03, under approval number K181479.
What company makes Ingenia Ambition S and Ingenia Ambition X?
Ingenia Ambition S and Ingenia Ambition X is manufactured by Philips Medical Systems Nederland B.V..
What is the FDA product code for Ingenia Ambition S and Ingenia Ambition X?
The FDA product code for Ingenia Ambition S and Ingenia Ambition X is LNH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.